Trial reportJournal of neurology, neurosurgery, and psychiatry2019
Long-term safety and efficacy of deutetrabenazine for the treatment of tardive dyskinesia.
Trial report in Journal of neurology, neurosurgery, and psychiatry, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02198794 (An Open-Label, Long-Term Safety Study of SD-809), which is not on this map. Cited by 24 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open-Label, Long-Term Safety Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia
Who cites it
24 citing papers in PubMed, 47 citations in OpenAlex.
- Efficacy and safety of valbenazine in Japanese patients with tardive dyskinesia: A multicenter, randomized, double-blind, placebo-controlled study (J-KINECT).Psychiatry and clinical neurosciences · 2022Trial
- Deutetrabenazine in Hyperkinetic Movement Disorders: VMAT2 Modulation From Choreiform Disorders to Hyperkinetic Dystonic Syndromes.Journal of central nervous system disease · 2026Review
- VMAT2 inhibitors for the treatment of tardive dyskinesia: a narrative review.CNS spectrums · 2025Review
- Article
- Unique and overlapping mechanisms of valbenazine, deutetrabenazine, and vitamin E for tardive dyskinesia.Schizophrenia (Heidelberg, Germany) · 2025Article
- Real-world experience with Deutetrabenazine management in patients with Huntington's disease using video-based telemedicine.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024Article
- An Evidence-Based Update on Anticholinergic Use for Drug-Induced Movement Disorders.CNS drugs · 2024Review
- Safety assessment of deutetrabenazine: real-world adverse event analysis from the FAERS database.Frontiers in pharmacology · 2024Article
- Vesicular monoamine transporter (VMAT) regional expression and roles in pathological conditions.Heliyon · 2023Review
- Exploring real-world symptom impact and improvement in well-being domains for tardive dyskinesia in VMAT2 inhibitor-treated patients via clinician survey and chart review.The mental health clinician · 2023Article
- Deuterium in drug discovery: progress, opportunities and challenges.Nature reviews. Drug discovery · 2023Review
- Sleep Dysfunction in Huntington's Disease: Impacts of Current Medications and Prospects for Treatment.Journal of Huntington's disease · 2023Review
- Clinical Utility of Deutetrabenazine as a Treatment Option for Chorea Associated with Huntington's Disease and Tardive Dyskinesia.Therapeutics and clinical risk management · 2023Review
- Movement disorders of the mouth: a review of the common phenomenologies.Journal of neurology · 2022Review
- Medical and Surgical Treatment for Medication-Induced Tremor: Case Report and Systematic Review.Movement disorders clinical practice · 2022Review
- Long-Term Deutetrabenazine Treatment for Tardive Dyskinesia Is Associated With Sustained Benefits and Safety: A 3-Year, Open-Label Extension Study.Frontiers in neurology · 2022Article
- Pathophysiology, prognosis and treatment of tardive dyskinesia.Therapeutic advances in psychopharmacology · 2022Review
- Patient perspective of tardive dyskinesia: results from a social media listening study.BMC psychiatry · 2021Article
- Assessment of the Impact of Tardive Dyskinesia in Clinical Practice: Consensus Panel Recommendations.Neuropsychiatric disease and treatment · 2021Review
- Tardive Dyskinesia in Older Persons Taking Antipsychotics.Neuropsychiatric disease and treatment · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 12 institutions in 2 countries.
Funding
Abstract
objectiveTo evaluate the long-term safety and efficacy of deutetrabenazine in patients with tardive dyskinesia (TD).
methodPatients with TD who completed the 12 week, phase 3, placebo-controlled trials were eligible to enter this open-label, single-arm study. The open-label study consisted of a 6 week dose-escalation phase and a long-term maintenance phase (clinic visits at Weeks 4, 6 and 15, and every 13 weeks until Week 106). Patients began deutetrabenazine at 12 mg/day, titrating up to a dose that was tolerable and provided adequate dyskinesia control, based on investigator judgement, with a maximum allowed dose of 48 mg/day (36 mg/day for patients taking strong cytochrome P450 2D6 (CYP2D6) inhibitors). Safety measures included incidence of adverse events (AEs) and scales used to monitor parkinsonism, akathisia/restlessness, anxiety, depression, suicidality and somnolence/sedation. Efficacy endpoints included the change in Abnormal Involuntary Movement Scale (AIMS) score (items 1 to 7) from baseline and the proportion of patients rated as 'Much Improved' or 'Very Much Improved' on the Clinical Global Impression of Change.
resultsA total of 343 patients enrolled in the extension study, and there were 331 patient-years of exposure in this analysis. The exposure-adjusted incidence rates of AEs with long-term treatment were comparable to or lower than those observed in the phase 3 trials. The mean (SE) change in AIMS score was -4.9 (0.4) at Week 54 (n = 146), - 6.3 (0.7) at Week 80 (n = 66) and -5.1 (2.0) at Week 106 (n = 8).
conclusionsOverall, long-term treatment with deutetrabenazine was efficacious, safe, and well tolerated in patients with TD. TRIAL REGISTRATION NUMBER: NCT02198794.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.